Clinical trial · Interventional
Study of Colon GVAX and Cyclophosphamide in Patients With Metastatic Colorectal Cancer
A Safety and Feasibility Study of an Allogeneic Colon Cancer Cell Vaccine Administered With a GM-CSF Producing Bystander Cell Line in Patients With Metastatic Colorectal Cancer
NCT00656123CI-TRIAL-00040078completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this study is to evaluate the safety and feasibility of vaccination with two irradiated allogeneic colorectal carcinoma cells administered with a GM-CSF producing bystander cell line in sequence with an immunomodulatory dose of Cyclophosphamide
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colon GVAX | Biological | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CY and colon GVAX
- interventionNames
- Biological: Colon GVAX
- Drug: cyclophosphamide
Primary outcomes (1)
- measure
- Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity
- timeFrame
- 3.5 years
- description
- When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v3) will be counted only once for a given subject.
Secondary outcomes (1)
- measure
- Percent Fold change in amount of interferon gamma-producing Ep-CAM-specific CD8 T cells after vaccination
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: * Documented metastatic colorectal cancer * ECOG Performance Status of 0 to 1 * Adequate organ function as defined by study-specified laboratory tests * Must use acceptable form of birth control through the study and for 28 days after final dose of study drug * Signed informed consent form * Life expectance \> 12 weeks Exclusion Criteria: * Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune, or other medical conditions * Systemically active steroid use * Another investigational product within 28 days prior to receiving study drug * Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug * Chemotherapy, radiation, or biological cancer therapy within 28 days prior to receiving study drug * No known history or evidence of CNS metastases \< 2 years. * Pregnant or lactating * Unwilling or unable to comply with study procedures
References
Publications (1)
- RESULTZheng L, Edil BH, Soares KC, El-Shami K, Uram JN, Judkins C, Zhang Z, Onners B, Laheru D, Pardoll D, Jaffee EM, Schulick RD. A safety and feasibility study of an allogeneic colon cancer cell vaccine administered with a granulocyte-macrophage colony stimulating factor-producing bystander cell line in patients with metastatic colorectal cancer. Ann Surg Oncol. 2014 Nov;21(12):3931-7. doi: 10.1245/s10434-014-3844-x. Epub 2014 Jun 19. PMID 24943235